Tainted Scope Infections Exceed Earlier Estimates

FDA releases new data


The number of potentially deadly infections from contaminated medical scopes is far higher than what federal officials previously estimated, according to a report from Kaiser Health News.

New data released by the FDA has indicated that as many as 350 patients at 41 medical facilities in the U.S. and worldwide were infected by or exposed to tainted gastrointestinal scopes between January 1, 2010, and October 31, 2015. In January, a Senate committee found 250 scope-related infections at 25 hospitals and clinics in the U.S. and Europe. That probe looked at a narrower period, from 2012 to 2015.

The FDA supplied the new information in response to a year-long inquiry by U.S. Rep. Ted Lieu (D-California) and staff of the House Oversight and Government Reform committee.

The FDA said it was not permitted by law to name the medical facilities involved in the 41 incidents it disclosed, and the device manufacturers weren’t identified, either.

In a February document sent to the House Oversight committee, the FDA listed 404 patient infections and 44 more patients who were exposed to contaminated duodenoscopes. But the regulators warned that these device reports “likely contain duplicate patient reporting,” and “we estimate the number of unique patients reported to be 300 to 350” for infections and exposure.

The FDA told the House panel that scope-related infections or contamination occurred at 30 facilities in the U.S. and at 11 facilities overseas.

Lieu said the House investigation uncovered significant gaps in existing law that contributed to a series of “superbug” outbreaks nationwide, including infections at UCLA’s Ronald Reagan Medical Center and Cedars–Sinai Medical Center in Los Angeles. Both outbreaks involved scopes from Olympus Corp., a device manufacturer based in Tokyo, Japan. At UCLA, three patients died and five more were sickened by antibiotic-resistant superbugs.

Lieu has introduced two bills aimed at improving patient safety in response to the House findings on the outbreaks.

“I was surprised at how much larger the number of infections was, and it made me even more upset about the harm these device manufacturers have caused,” Lieu said in an interview. “There are current gaps in the law we need to close to make sure these situations don’t happen again.”

Meanwhile, federal prosecutors continue to investigate Olympus and two smaller device manufacturers, Pentax and Fujifilm, over their role in the outbreaks.

The duodenoscope infections occurred during a procedure known as endoscopic retrograde cholangiopancreatography (ERCP), in which a scope is threaded down a person’s throat to diagnose and treat problems in the digestive tract, such as gallstones, cancers, and blockages in the bile duct. More than 650,000 ERCP procedures are performed in the U.S. each year.

In January, Olympus Corp. began a voluntary recall of its duodenoscopes and pledged to make repairs to reduce the risk of contamination. The scopes remain in use while the company works on those alterations, which it expects to finish by August.

Since an FDA warning went out in February 2015, health officials have urged all hospitals to review their cleaning procedures for these reusable scopes and to consider additional steps to minimize the infection risk. In response, many hospitals started testing scopes for contamination after cleaning and holding them in quarantine for 48 hours to check for bacterial growth.